Insights On Quality Assurance

1. Accelerate Review Times And Deliver Better Quality Documents 7/14/2025

   Discover expert strategies to streamline your document review process with Diahann Homer and Kelly Spencer to boost quality, reduce cycles, and ensure compliance in medical writing.

2. Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines 8/6/2025

   As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

3. Three Vital Steps To QMS Implementation 11/7/2024

   When selecting a QMS, it may feel like the most challenging step is making the purchase. This is not necessarily the case. Read more about the challenges of implementing an effective QMS.

4. How CMOS/CDMOS Drive Industry Growth 4/16/2025

   From minimizing costs and accessing advanced tech to speeding market entry, dive into how outsourcing drug development and manufacturing to CMOs/CDMOs offers strategic advantages.

5. How Automation Can Help Fast Track Vaccines 11/1/2023

   The urgency of the coronavirus pandemic has demonstrated the need for expedited vaccine development. Discover how digital tools can help speed up the vaccine manufacturing process.

6. Enhancing Ethylene Oxide Sterilization Processes 8/15/2025

   PCDs are patented devices designed to meet the demands of EO sterilization. Gain insight into how they support process development, validation, and monitoring with reliable, reproducible performance.

7. The Role Of The Technical Transfer Executive Sponsor 10/30/2023

   Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

8. How To Adopt CSA For Streamlined Computer System Validation 7/1/2025

   Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

9. Conquering Challenges In Viral Vector Production 8/27/2025

   Scaling gene therapy demands precision and actionable data. Discover how integrated technologies like ultracentrifugation and mass spectrometry enhance AAV yield, purity, and characterization.

10. Achieving Licensing For A Healthcare Solution 6/16/2025

    Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.